Method for double row fixation of tendon to bone

ABSTRACT

A system and method for soft tissue to bone repair employing at least one suture anchor combined with at least one knotless fixation device. The method for soft tissue to bone fixation includes: (i) providing a first medial row constructed with a first plurality of fixation devices, at least one of the first plurality of fixation devices is an anchor; and (ii) providing a second lateral row constructed with a second plurality of fixation devices, at least one of the second plurality of fixation devices is a knotless fixation device, and suture or tape or allograft/biological component extending over the soft tissue and secured in place by the anchors in the first and second medial rows.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 11/700,916, filed Feb. 1,2007, now U.S. Pat. No. 8,012,174, which claims the benefit of U.S.Provisional Application No. 60/763,915, filed Feb. 1, 2006, the entiredisclosures are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to methods of arthroscopic surgery and,more specifically, to an improved method of attaching tissue to bone,such as rotator cuff repair.

BACKGROUND OF THE INVENTION

When soft tissue tears away from bone, reattachment becomes necessary.Various devices, including sutures, screws, staples, wedges, anchors andplugs have been used in the prior art to secure soft tissue to bone.Surgical methods utilizing suture anchors alone are disadvantageous forreattachment of large areas of detached tissue because they often do notallow good tissue to bone contact.

Reattachment of soft tissue to bone typically requires the surgeon topass suture material through selected tissue, form a plurality ofsurgical knots extracorporeally and then move the knots into positionadjacent the desired tissue to be sutured. In such procedures, thesurgeon must manually tie the knots on the suture strands after thesuture is threaded through the selected tissues to be sutured. Knottying during surgery, particularly arthroscopic surgery, is tedious andtime-consuming. There is also a tendency for the knots to deform orcollapse as the surgeon manually forces the knots down into the properposition. Also, the suture knots often are exposed to abrasion orcutting by sharp or rough areas along the walls of the bone canal intowhich anchors are typically inserted to provide fixation of tendon tobone.

Accordingly, a need exists for an improved method for attaching softtissue to bone which does not require multiple suture knots and whichallows the tendon to remain securely in place until the ligamentsnaturally attach to bone. A method of threading suture through a tendonwith maximum suture fixation strength, as well as a method of securingthe tendon to bone that allows for accelerated tendon healing to boneare also needed.

BRIEF SUMMARY OF THE INVENTION

The present invention provides a system and method for soft tissue tobone repair employing at least one suture anchor combined with at leastone knotless fixation device.

More specifically, the present invention provides a method for tendon tobone fixation which includes: (i) providing a first medial rowconstructed with a first plurality of fixation devices, at least one ofthe first plurality of fixation devices being an anchor; (ii) providinga second lateral row constructed with a second plurality of fixationdevices, at least one of the second plurality of fixation devices beinga knotless fixation device; and (iii) providing a structure comprisingan element selected from the group consisting of suture, tape andallograft/biological component, and extending the structure over thesoft tissue so that the structure is secured in place by the anchors.

Other features and advantages of the present invention will becomeapparent from the following description of the invention, which refersto the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view illustrating an initial step of a method ofarthroscopic rotator cuff repair according to an exemplary embodiment ofthe present invention.

FIG. 2 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 1.

FIG. 3 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 2.

FIG. 4 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 3.

FIG. 5 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 4.

FIG. 6 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 5.

FIG. 7 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 6.

FIG. 8 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 7.

FIG. 9 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 8.

FIG. 10 is a side view of the structure of FIG. 1 and at a stepsubsequent to that shown in FIG. 9.

FIGS. 11( a)-(g) illustrate various steps of assembling a driver with aswivel knotless fixation device employed during a knotless repairaccording to the present invention.

FIG. 12 is a first enlarged side view of the swivel anchor implantillustrated in FIGS. 11( a)-(g).

FIG. 13 is a second enlarged side view of the swivel anchor implant ofFIG. 12.

FIG. 14 is a side view of the structure of FIG. 1 according to a secondexemplary embodiment of arthroscopic rotator cuff repair of the presentinvention.

FIG. 15 is a side view of the structure of FIG. 1 according to a thirdexemplary embodiment of arthroscopic rotator cuff repair of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1 through 15 illustrate systems andmethods of attaching a tendon to bone according to the presentinvention. For exemplary purposes only, the invention will be describedbelow with reference to an arthroscopic rotator cuff repair. However,the invention is not limited to this exemplary embodiment and hasapplicability to any reattachment of soft tissue to bone.

The methods of the present invention enhance footprint compression andallow for accelerated tendon healing to bone that is achieved withminimal knot tying. The repair consists of a tied medial row constructedwith at least one suture anchor combined with knotless lateral fixationusing at least one knotless fixation device. Preferably, the repairconsists of a tied medial row constructed with two suture anchors (suchas two Arthrex 5.5 mm Bio-Corkscrew® FT anchors, for example) combinedwith knotless lateral fixation using at least one knotless fixationdevice, preferably at least two knotless fixation devices (such as twoArthrex 3.5 mm PushLock™ anchors, two Arthrex SwiveLock™ anchors, acombination of the PushLock™ and SwiveLock™ anchors, or a combination ofat least one of a PushLock™ and SwiveLock™ anchor with another knotlessfixation device or with other fixation device, among others). The resultis a quick, secure and low profile repair with excellent contact betweentendon and bone.

FIG. 1 illustrates a side view of a human shoulder of a patientundergoing a rotator cuff repair in accordance with an exemplaryembodiment of the present invention. Although this particular embodimentwill be illustrated below with reference to FIGS. 1-10 and withreference to only a particular knotless fixation device (such as Arthrex“PushLock” anchor), the invention is not limited to this particularembodiment and contemplates additional embodiments wherein any knotlessfixation device may be employed, depending on the characteristics of therepair site and of the particular application.

The patient may be positioned in the beach chair position using theArthrex Beach Chair Lateral Traction Device or in a lateral decubitusposition using the Arthrex 3-Point Shoulder Distraction System. Accessto the subacromial space is facilitated with a variety of cannulas.

First, and as illustrated in FIG. 1, the mobility of the tear isassessed using, for example, a tissue grasper 10 such as the ArthrexKingFisher™ Suture Retriever/Tissue Grasper, to determine whether a U orL-shaped component exists. Where large tears extend to the superioraspect of the glenoid, margin convergence suturing is performed toreduce volume and strain on the repair. Subsequently, the length andwidth of the rotator cuff footprint is assessed and a bleeding bed forenhanced tendon to bone healing may be formed. This may be accomplishedwith a burr to perform a light dusting of the greater tuberosity, or byusing a chondro pick to microfracture the footprint and maximizevascular channels.

FIG. 2 illustrates the preparation of two pilot holes for two sutureanchors that will be inserted in the medial row. A punch may be employedadjacent to the articular margin of the humerus and at about 45° angleto form the two pilot holes.

Subsequent to the formation of the pilot holes, and as shown in FIG. 3,a suture anchor 30 is placed in the pre-formed hole 32. As shown in FIG.4, two suture anchors 30 are placed in the two pre-formed holes 32 in amedial row. These anchors assure full contact of the detached tendon 34along the medial footprint of the greater tuberosity. In an exemplaryembodiment, at least one of the two suture anchors is a fully-threadedbioabsorbable suture anchor having a loop inserted into the sutureanchor, and as disclosed and described in U.S. Patent ApplicationPublication No. 2007/0060922, entitled “Fully-Threaded BioabsorbableSuture Anchor,” the disclosure of which is hereby incorporated byreference in its entirety. In other embodiments, at least one of the twosuture anchors may be an Arthrex Biocorkscrew™, disclosed in U.S. PatentApplication Publication No. 2004/0106950, the disclosure of which ishereby incorporated by reference in its entirety, having an eyelet andloaded with a single or double strands of sutures.

In an exemplary embodiment, suture anchors 30 have a flexible elongatedmember 40 (for example, suture 40) preferably attached to a proximal end42, as illustrated in FIG. 4. One strand of suture 40 from each anchor30 (preferably opposite colors) is removed. Using a suture retrieverinstrument 44, one of the four remaining sutures 40 is retrieved throughthe lateral (or anterolateral) cannula 46 and is passed through thetendon 34 using a suture passer instrument 44. This step is repeated forthe three remaining sutures 40 to create a horizontal mattressconfiguration. When large tears are present, and if desired, all suturestrands may be used to obtain additional medial fixation. In this case,the additional strands would be tied and cut.

Referring now to FIG. 5, the medial row is tied leaving the suture tails40 uncut. As described below, these suture tails 40 will be draped overthe lateral aspect of the tendon 34 and will be held in place with twoknotless fixation devices. As also shown in FIGS. 5 and 6, two pilotholes 60 for the knotless fixation devices 62 are formed approximately5-10 mm distal to the lateral edge of the greater tuberosity using apunch, for example, through the lateral (or anterolateral) cannula 46.In an exemplary embodiment, at least one of the two knotless fixationdevices 62 is a fixation device (an Arthrex “PushLock®” anchor) asdisclosed and described in U.S. Patent Application Publication No.2004/0093031, the disclosure of which is hereby incorporated byreference in its entirety, or an Arthrex “SwiveLock®” anchor asdescribed below with reference to FIGS. 11-13.

As illustrated in FIG. 6, one suture strand 40 from each suture anchor30 is retrieved through the lateral (or anterolateral) cannula 46. Bothsuture strands 40 are then threaded through an eyelet 64 of the knotlessfixation device 62 (for example, through the eyelet of the PushLock®anchor or of the SwiveLock® anchor) on the distal end 66 of the driver68.

Subsequently, and as shown in FIG. 7, the distal tip 66 of the knotlessfixation device 62 is brought to the edge of the pilot hole 60 whileholding onto the suture tails 40. This will reduce the tendon 34 to itsdesired position on the footprint. Also, the knot stack from the medialsuture anchors 30 is forced to lie flat against the tendon 34 minimizingpotential impingement issues from the suture 40.

The driver 68 is then completely advanced into the pilot hole 60 beyondthe first laser line, until the anchor body 63 contacts the bone and thetissue tension is evaluated (FIG. 8). If it is determined that thetension is not adequate, the driver 68 can be backed out and the tensionreadjusted. Alternatively, additional tension may be applied, whileleaving the driver 68 in place, by pulling on each suture strand 40independently. A mallet 80 may be employed to impact the anchor body 63into the pilot hole 60 until the second laser line is flush with thehumerus.

Referring now to FIG. 9, the driver 68 is turned counterclockwise todisengage the eyelet (within pilot hole 60) from the driver shaft. Thesutures 40 are then cut flush using a suture cutter (not shown). Thesteps described above with reference to FIGS. 6 through 9 aresubsequently repeated for the second knotless fixation device 62 (forexample, a second PushLock® anchor) to obtain the criss-cross suturingarrangement 82 of FIG. 10 having double rows of fixation devices. Thecriss-cross suturing arrangement 82, together with the two sutureanchors 30 combined with knotless lateral fixation using the twoknotless fixation devices 62 form exemplary repair system 100 (FIG. 10)of the present invention.

FIGS. 11-13 illustrate exemplary steps of the installation of knotlessfixation devices with a swivel anchor implant 200 on driver 68 during aknotless method of attaching tissue to bone according to otherembodiments of the present invention. The knotless fixation devices witha swiveling implant 200, are sold by Arthrex, Inc. under the tradenameSwiveLock® and may be used in lieu of the exemplary PushLock® anchorsdescribed above with reference to the exemplary knotless rotator cuffrepair described in FIGS. 1 through 10. The installation technique issimilar to the one described above, except that the lateral fixation isaccomplished by threading suture through an implant 200 that swivels onthe shaft of the driver, and the implant is secured by an anchor that isscrewed (by rotating the shaft of the driver), rather than pushed, overthe implant.

As shown in FIGS. 11( a)-(f), a driver 68 is used to install theknotless fixation devices with a swiveling implant. Driver 68 features athin cannulated rod 69 passing slidably and rotatably through acannulated driver assembly. The tip of thin cannulated rod 69 is adaptedto accept swivel anchor implant 200 within the cannulation at its tip,preferably via a snap fit. Cannulated rod 69 has a hexagonal outersurface for receiving anchor body (i.e., a screw) 90 having acorresponding cannulation.

During installation of the knotless anchor having a swiveling implant200, the screw 90 is first inserted onto cannulated rod 69 of the driver68. As shown in FIGS. 11( a) and (b), screw 90 is loaded onto rod 69 andthen fully seated on the shaft end of the driver. FIG. 11( c)illustrates the swivel anchor implant 200. Traction sutures 71 extendingfrom the proximal end of the swivel anchor implant 200 are threadedthrough the cannulation of the driver 68 (FIG. 11( c)). Subsequently,the swivel anchor implant 200 is seated on the driver tip and untiladvanced until it snaps onto place (FIG. 11( d)). A protective tube 94(FIG. 11( e)) may be placed over the tip of the assembly for shippingpurposes. The traction sutures 71 may be looped around the driverhandle, as shown in FIGS. 11( f) and (g), and secured in a cleat 98 toprevent the implant 200 from becoming prematurely detached from thedriver.

The knotless fixation devices, whether of the first embodiment(PushLock® anchors) or the second embodiment (SwiveLock® anchors)advantageously minimize or eliminate the need to tie knots. The use ofsuch anchors also provides secure fixation of the suture construct—thesecure suture construct results from the suture being pushed into apilot hole on the lateral row and held tightly by an anchors.

The sutures employed in the method of the present invention may beformed of any flexible material. In the preferred embodiment, thesutures forming the construct are made of a high strength suturematerial, such as Arthrex FiberWire® suture, which is described in U.S.Pat. No. 6,716,234 to Grafton et al., the disclosure of which isincorporated by reference in its entirety. In additional embodiments,the suture strands may be FiberWire® sutures of alternating colors tomaximize repair strength, aid in suture management and provide superiortying characteristics.

In another preferred embodiment, any flexible elongated member, such astape, rather than suture, may be employed, to further improve tissuecompression, improve fixation in the anchors, and to further holdcollagen or bone marrow aspirate better than suture. Preferably, thetape, such as the high strength suture tape disclosed in U.S. PatentApplication Publication No. 2005/0192631, the disclosure of which isincorporated by reference herein, is braided and rectangular-like incross-section. In another preferred embodiment, an allograft orbiological component may be used instead of suture or tape. Theallograft or biological component may be comprised of tendon orpericardium, for example, which provides improved tissue repair. In yetadditional embodiments, any combination of suture, suture tape, andallograft or biological component may be employed, depending on thecharacteristics of the specific surgical repair and/or as desired.

According to additional exemplary embodiments of the present invention,the present invention may be further employed in conjunction withallograft or porous collagen material that may be optionally hydratedwith bone marrow aspirate. In the exemplary embodiments illustrated inFIGS. 14 and 15, repair systems 400, 500 of the present inventioncomprise, for example, the repair system 100 (described with referenceto FIG. 10) and implant material 250, 350 provided arthroscopically(preferably under the tissue prior or above the tissue) prior toimplanting the lateral row of the repair system 100.

In exemplary embodiments, implant material 250, 350 may be porouscollagen material (BioSponge™) or tendon allograft (AlloBridge™) thatcan be readily hydrated or impregnated with a hydrating solutioncomprising aspirated bone marrow. The hydrating solution may consistessentially of bone marrow, preferably consisting essentially ofautogenous bone marrow. Alternatively, the hydrating solution maycomprise additional elements, such as various growth factors such ashyaluronic acid, antiseptics and/or antibiotics and medicine materials,in addition to or in lieu of the bone marrow. The BioSponge™ 250 (FIG.14) or AlloBridge™ 350 (FIG. 15) impregnated or hydrated with bonemarrow can act as carrier of bone marrow at the repair site, the bonemarrow promoting a biological response to damaged tissue and reinforcingthe repair of such damaged tissue. The implanted material 250, 350 maybe provided at various locations of the repair site (for example, abovethe tissue, under the tissue, or extending from the tissue) dependingupon the characteristics of the repair site and of the damaged tissue.

During the surgical repair, the bone marrow aspirate provides a cellsuspension that can be readily processed intraoperatively for immediateimplantation. According to exemplary embodiments, the bone marrowaspirate may be withdrawn from the iliac crest or may be aspirated fromthe femur and humerus. Once the bone marrow aspirate is aspirated (witha syringe, for example) from an aspirate region such as the humeralhead, the BioSponge™ or AlloBridge™ is hydrated with the bone marrow andthen the hydrated BioSponge™ or AlloBridge™ is provided arthroscopically(for example, under the tissue) prior to implanting the lateral rowimplants of system 100. Alternatively, or additionally, bone marrowaspirate may be injected directly or localized to a repair site, tofacilitate healing.

The bodies of the fixation devices of the present invention may bepreferably formed of a translucent or transparent polymer material, andare preferably made of bioabsorbable materials such as polyglycolic orpolylactic acid polymers.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art.Accordingly, it is not intended that the present invention be limited tothe illustrated embodiments, but only by the appended claims.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A knotless method of attaching soft tissue tobone, comprising: inserting a first anchor with a length of sutureattached thereto into a first hole in the bone; passing the sutureattached to the first anchor up through and over the soft tissue;inserting an end of the suture through an eyelet of an implant;positioning the implant over a second hole in the bone which is notunderneath the soft tissue and tensioning the suture as appropriate;advancing the implant into the second hole in the bone; and inserting abody of a second anchor into the second hole in the bone, over theimplant, to secure the suture in the second hole without tying anyknots.